JACKSONVILLE, FL -- 07/31/07 --
The American Association of Clinical
Endocrinologists (AACE), along with the rest of the medical community, has
watched with concern the debate regarding usage of GlaxoSmithKline's
rosiglitazone (Avandia) in diabetes and the question of whether it
increases cardiovascular risk. AACE welcomes the recommendation of the Food
and Drug Administration endocrine advisory panel, which voted almost
unanimously yesterday that Avandia remain in the US market.
At the same time, AACE recognizes the strong statement of the panel that
the drug may increase risk of cardiovascular disease (CVD). We share the
concerns of many on the panel that the methodology used in suggesting an
association between Avandia and CVD was far from optimal. Three
well-designed long-term randomized controlled studies, the Bypass
Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D), the
Action to Control Cardiovascular Risk in Diabetes (ACCORD), and the
Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in
Diabetes (RECORD) trials, will greatly enhance our understanding of whether
or not this agent helps to decrease diabetes complications.
Physicians can continue to treat persons with diabetes who are well
controlled with Avandia, knowing that it has been shown useful and
effective in controlling glucose, a crucial step to preventing diabetes
complications. AACE will continue to support the development of approaches
to manage the issues of weight gain, of fluid retention, and of reduced
bone mass in diabetic patients receiving both Avandia and Takeda's
pioglitazone (Actos), to optimize clinical decision-making in the
appropriate use of these important glucose-lowering medicines.
About AACE
AACE is a professional medical organization with more than 6,000 members in
the United States and 84 other countries. Founded in 1991, AACE is
dedicated to the optimal care of patients with endocrine problems. AACE
initiatives inform the public about endocrine disorders. AACE also
conducts continuing education programs for clinical endocrinologists,
physicians whose advanced, specialized training enables them to be experts
in the care of endocrine disease, such as diabetes, thyroid disorders,
growth hormone deficiency, osteoporosis, cholesterol disorders,
hypertension and obesity. For further information about AACE and the Annual
Meeting, visit the AACE web site at www.aace.com.
Contact:
American Association of Clinical Endocrinologists
Bryan Campbell
(Email Contact)
904-353-7878
